Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Creatinine, sodium citrate, citric acid hydrate, sodium hydroxide, water for injection.

6.2. Incompatibilities

Dexamethasone sodium phosphate is physically incompatible with daunorubicin, doxorubicin and vancomycin and should not be admixed with solutions containing these drugs. Also incompatible with doxapram HCl and glycopyrrolate in syringe.

6.3. Shelf-life

The expiry date of the product is indicated on the packaging materials 
After opening: the product must be used immediately.
Chemical and physical in-use stability has been demonstrated for 48 hours at 25°C protected from light when diluted with the infusion fluids listed in 6.6. From a microbiological point of view, the product should be used immediately. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution have taken place in controlled validated aseptic conditions.


6.4. Special precautions for storage

Store below 25°C and protected from light in original carton pack.
For storage conditions after dilution of the medicinal product, see section 6.3.
Discard any unused product at the end of each operating session.

6.5. Nature and contents of container
1 ml clear glass ampoule. Box of 5 and 10 ampoules.

6.6. Special precautions for disposal

Use with infusion fluids
Dexamethasone can be diluted with the following infusion fluids: sodium chloride 0.9% glucose 5%
Using these infusion fluids, Dexamethasone Injection can also be injected into the infusion line without causing precipitation of the ingredients.

For single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.